Accelerate Diagnostics Inc: Medical Device Recall in 2018 - (Recall #: Z-1529-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

Product Classification:

Class II

Date Initiated: March 14, 2018

Date Posted: May 2, 2018

Recall Number: Z-1529-2018

Event ID: 79631

Reason for Recall:

The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).

Status: Terminated

Product Quantity: 95 kits

Code Information:

Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.

Distribution Pattern:

Distributed to IL, TX, CA, SC, and DE.

Voluntary or Mandated:

Voluntary: Firm initiated